Steroid Treatment in Preterm Babies Shows No Increased Harm, Study Finds
National study by Imperial College London finds low-dose hydrocortisone treatment for extremely preterm babies is not linked to higher risk of harm.
By Priya Shah
••3 min read
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Generic image of a baby's hand holding a medical thermometer in a hospital setting.
A national study involving thousands of extremely preterm babies in England and Wales has found no evidence that low-dose hydrocortisone treatment is associated with a higher risk of harm, despite some concerns.
Researchers at Imperial College London have conducted a national study examining the potential risks of giving extremely preterm babies low-dose hydrocortisone treatment within their first ten days of life. This treatment is sometimes administered to help prevent long-term lung complications and to address concerns about an increased risk of life-threatening intestinal perforation.
The study, published in the journal Archives of Disease in Childhood – Fetal and Neonatal Edition, found no evidence of an increased risk of bowel complications with the treatment. However, researchers did observe a higher rate of death before discharge among babies classified as receiving hydrocortisone. They caution that as this was an observational study, it is not possible to definitively establish whether hydrocortisone was a direct cause of this difference, or if other factors were involved.
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"We cannot say that this treatment is the cause of infant deaths, as the evidence from this study does not support that. But what we can say, is that this is an important finding which requires further investigation. Extremely premature babies are a high-risk patient cohort, more likely to have health issues, so we need to take care interpreting these findings. Ultimately, we hope these findings help to inform further research and improve the clinical care and health of babies born premature."
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"In this study we observed higher mortality among babies classified as receiving early hydrocortisone. This is an important finding, but the study cannot tell us whether hydrocortisone contributed to those deaths. We used routinely collected clinical data and could not be certain exactly why hydrocortisone was prescribed for each baby, as it can be used to treat a number of conditions. Babies who received it may therefore have differed from those who did not in ways our analysis could not fully account for. Some may have received it because they were already unwell. Our findings should be considered alongside evidence from randomised trials when assessing the potential benefits and risks of early hydrocortisone."
The research team analysed data from 15,746 babies born before 28 weeks of gestation between 2016 and 2023. In a matched analysis, 21.3% of babies receiving early hydrocortisone died before discharge, compared to 16.2% in the comparison group. The study was primarily designed to investigate focal intestinal perforation, a serious bowel complication, and found no increased rate in the hydrocortisone group. While the mortality finding warrants further investigation, it should not be interpreted as evidence that the treatment caused deaths.
The researchers noted that the clinical reason for prescribing hydrocortisone was not available in the dataset, meaning babies who received it might have already been unwell. Differences in post-treatment illness or care between neonatal units could also influence the results. Earlier randomised trial evidence has not established an increase in mortality with this treatment.
